I. Essential Duties and Responsibilities
Laboratory Technical Competency
- Ensures laboratory has all relevant supplies, equipment, reagents, and inventory while maintaining and improving workspace organization and cleanliness
- Performs laboratory activities supporting process development programs for pharmaceutical and biotechnology products within a contract development and manufacturing (CDMO) environment.
- Seeks to collaboratively solve laboratory, manufacturing support, and process development challenges using established laboratory procedures, professional concepts, company policies, and scientific principles.
- Plans and executes moderate to complex laboratory experiments, process evaluations, sample preparation, solution preparation, equipment setup, and process development studies in accordance with approved protocols and procedures.
- Operates, calibrates, maintains, and performs troubleshooting of laboratory equipment while initiating and documenting maintenance activities as required
- Identifies and communicates opportunities to improve laboratory efficiency by recommending enhancements to existing procedures and laboratory practices within established guidelines
Quality Competency
- Maintains accurate laboratory notebooks, electronic laboratory records, calculations, and technical documentation in accordance with Good Documentation Practices (GDP) and company procedures.
- Maintains compliance with company policies, safety procedures, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), laboratory procedures, and applicable regulatory requirements.
- Analyzes experimental data, evaluates results, identifies routine trends, and communicates technical summaries to support process development activities and project objectives.
Manufacturing Technical Competency:
- Executes process development studies and provides technical input to support process optimization, process characterization, technology transfer activities, change in scale activities, manufacturing support, and continuous improvement initiatives.
- Maintains relevant process development supplies, equipment, reagents, and inventory while ensuring workspace organization and cleanliness.
Interpersonal Competency:
- Provides guidance and training to less experienced laboratory personnel on routine laboratory techniques, equipment operation, documentation practices, and standard operating procedures.
- Collaborates with internal colleagues to support development programs and project timelines
- Process Development, Analytical Development, Manufacturing, Quality Control, Quality Assurance, Engineering, Project Management and other cross-functional teams.
Business Process Competency:
- Identifies and communicates observations, technical findings, experimental results, and project updates to enable completion of Project Management goals, milestones, communications, and deliverables.
- Maintains confidentiality of proprietary, customer, and company information.
- Performs other duties as assigned.
- Requires a minimum of two (2) years of related manufacturing, laboratory, graduate research, or process development experience. Exposure to synthetic, purification, or bioprocessing equipment and analytical instrumentation is recommended.
- Undergraduate degree, or industrial experience in a Technical Field. Recommended exposure to Life Sciences, or a related scientific discipline.
- Chemical Engineering, Biochemical Engineering, Biomedical Engineering
- Chemistry, Biology, Biochemistry, Materials Science
- Process Technology, Biotechnology, Chemical Engineering Technology,
- Experience supporting pharmaceutical, biotechnology, life sciences, CDMO, academic research, or other regulated laboratory or manufacturing environments is valued.
- Intermediate knowledge of laboratory techniques, scientific principles, experimental design, data collection and analysis, laboratory instrumentation, and process development methodologies.
- Intermediate knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), laboratory safety requirements, and scientific documentation standards.
- Demonstrated ability to independently execute laboratory experiments, analyze experimental data, identify routine trends, troubleshoot laboratory issues, and support process development activities.
- Experience operating laboratory instrumentation and maintaining accurate laboratory documentation in electronic and paper-based systems.
- Strong analytical, organizational, and problem-solving skills with the ability to manage multiple laboratory assignments while meeting project timelines.
- Effective written and verbal communication skills with the ability to prepare technical documentation, communicate experimental observations, and provide guidance on routine laboratory procedures.
- Ability to maintain confidentiality and comply with company policies and applicable regulatory requirements.
III. Physical Requirements
- Must be able to pass pre-employment drug screening and background check for employment consideration.
- Must be able to lift 25 lbs.
- Must be able to sit or stand for long periods of time.
- Employees must be able to wear a respiratory protection (filtering face piece, ½ face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function.
- Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function.
- Employees performing visual inspection of primary packaging (e.g., vials and particulates) must be able to accurately detect color and have 20/20 vision, with or without corrective lenses.